Trial Outcomes & Findings for Early Bactericidal Activity, Safety & Tolerability of Oral GSK3036656 in a Dual Combination With Novel and Established Antitubercular Agents, or Standard of Care in Adults With Rifampicin Susceptible Pulmonary Tuberculosis (NCT NCT05382312)
NCT ID: NCT05382312
Last Updated: 2026-06-17
Results Overview
Baseline was defined as the mean of Day -2 and Day -1. If data was available at only one of these timepoints, then that value was used as baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
127 participants
Primary outcome timeframe
At Baseline and at days 1, 2, 3, 4, 6, 8, 10, 12 and 14
Results posted on
2026-06-17
Participant Flow
A total of 127 participants were enrolled out of which 125 started the study.
Participant milestones
| Measure |
Standard of Care for Drug-sensitive Tuberculosis (DS - TB)_Cohort 1
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Bedaquiline
Participants received GSK3036656 20 milligram (mg) + bedaquiline 400 mg once daily for 14 days; loading doses: 50 mg GSK3036656 (Day 1), 700 mg bedaquiline (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
|
GSK3036656 + Delamanid
Participants received GSK3036656 20 mg + delamanid 300 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Delamanid + Bedaquiline
Participants received delamanid 300 mg + bedaquiline 400 mg once daily for 14 days; bedaquiline loading doses: 700 mg (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
|
GSK3036656 + BTZ-043
Participants received GSK3036656 20 mg + BTZ-043 1000 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Standard of Care for DS - TB_Cohort 2
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Pretomanid
Participants received GSK3036656 20 mg + pretomanid 200 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
GSK3036656 + Linezolid
Participants received GSK3036656 20 mg + linezolid 600 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
GSK3036656 + Moxifloxacin
Participants received GSK3036656 20 mg + moxifloxacin 400 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Standard of Care for DS TB_Cohort 3
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
9
|
14
|
15
|
16
|
14
|
3
|
16
|
13
|
14
|
11
|
|
Overall Study
COMPLETED
|
9
|
14
|
15
|
16
|
13
|
3
|
16
|
12
|
13
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
1
|
1
|
1
|
Reasons for withdrawal
| Measure |
Standard of Care for Drug-sensitive Tuberculosis (DS - TB)_Cohort 1
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Bedaquiline
Participants received GSK3036656 20 milligram (mg) + bedaquiline 400 mg once daily for 14 days; loading doses: 50 mg GSK3036656 (Day 1), 700 mg bedaquiline (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
|
GSK3036656 + Delamanid
Participants received GSK3036656 20 mg + delamanid 300 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Delamanid + Bedaquiline
Participants received delamanid 300 mg + bedaquiline 400 mg once daily for 14 days; bedaquiline loading doses: 700 mg (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
|
GSK3036656 + BTZ-043
Participants received GSK3036656 20 mg + BTZ-043 1000 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Standard of Care for DS - TB_Cohort 2
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Pretomanid
Participants received GSK3036656 20 mg + pretomanid 200 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
GSK3036656 + Linezolid
Participants received GSK3036656 20 mg + linezolid 600 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
GSK3036656 + Moxifloxacin
Participants received GSK3036656 20 mg + moxifloxacin 400 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Standard of Care for DS TB_Cohort 3
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Participant reached protocol-defined stopping criteria
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Early Bactericidal Activity, Safety & Tolerability of Oral GSK3036656 in a Dual Combination With Novel and Established Antitubercular Agents, or Standard of Care in Adults With Rifampicin Susceptible Pulmonary Tuberculosis
Baseline characteristics by cohort
| Measure |
Standard of Care for Drug-sensitive Tuberculosis (DS - TB)_Cohort 1
n=9 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Bedaquiline
n=14 Participants
Participants received GSK3036656 20 milligram (mg) + bedaquiline 400 mg once daily for 14 days; loading doses: 50 mg GSK3036656 (Day 1), 700 mg bedaquiline (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
|
GSK3036656 + Delamanid
n=15 Participants
Participants received GSK3036656 20 mg + delamanid 300 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Delamanid + Bedaquiline
n=16 Participants
Participants received delamanid 300 mg + bedaquiline 400 mg once daily for 14 days; bedaquiline loading doses: 700 mg (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
|
GSK3036656 + BTZ-043
n=14 Participants
Participants received GSK3036656 20 mg + BTZ-043 1000 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Standard of Care for DS - TB_Cohort 2
n=3 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Pretomanid
n=16 Participants
Participants received GSK3036656 20 mg + pretomanid 200 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
GSK3036656 + Linezolid
n=13 Participants
Participants received GSK3036656 20 mg + linezolid 600 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
GSK3036656 + Moxifloxacin
n=14 Participants
Participants received GSK3036656 20 mg + moxifloxacin 400 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Standard of Care for DS TB_Cohort 3
n=11 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
Total
n=125 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
33.3 YEARS
STANDARD_DEVIATION 7.79 • n=9 Participants
|
31.5 YEARS
STANDARD_DEVIATION 8.70 • n=27 Participants
|
32.9 YEARS
STANDARD_DEVIATION 9.01 • n=267 Participants
|
33.1 YEARS
STANDARD_DEVIATION 7.49 • n=265 Participants
|
33.9 YEARS
STANDARD_DEVIATION 7.37 • n=568 Participants
|
46.3 YEARS
STANDARD_DEVIATION 10.12 • n=22 Participants
|
35.4 YEARS
STANDARD_DEVIATION 11.02 • n=23 Participants
|
36.1 YEARS
STANDARD_DEVIATION 12.15 • n=22 Participants
|
31.6 YEARS
STANDARD_DEVIATION 7.80 • n=178 Participants
|
34.6 YEARS
STANDARD_DEVIATION 11.33 • n=116 Participants
|
33.9 YEARS
STANDARD_DEVIATION 9.32 • n=2 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=267 Participants
|
3 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
1 Participants
n=23 Participants
|
1 Participants
n=22 Participants
|
2 Participants
n=178 Participants
|
2 Participants
n=116 Participants
|
13 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=9 Participants
|
12 Participants
n=27 Participants
|
14 Participants
n=267 Participants
|
13 Participants
n=265 Participants
|
14 Participants
n=568 Participants
|
3 Participants
n=22 Participants
|
15 Participants
n=23 Participants
|
12 Participants
n=22 Participants
|
12 Participants
n=178 Participants
|
9 Participants
n=116 Participants
|
112 Participants
n=2 Participants
|
|
Race/Ethnicity, Customized
ASIAN
|
0 Participants
n=9 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
0 Participants
n=265 Participants
|
0 Participants
n=568 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=178 Participants
|
0 Participants
n=116 Participants
|
1 Participants
n=2 Participants
|
|
Race/Ethnicity, Customized
BLACK OR AFRICAN AMERICAN
|
9 Participants
n=9 Participants
|
13 Participants
n=27 Participants
|
15 Participants
n=267 Participants
|
16 Participants
n=265 Participants
|
14 Participants
n=568 Participants
|
3 Participants
n=22 Participants
|
16 Participants
n=23 Participants
|
13 Participants
n=22 Participants
|
14 Participants
n=178 Participants
|
11 Participants
n=116 Participants
|
124 Participants
n=2 Participants
|
PRIMARY outcome
Timeframe: At Baseline and at days 1, 2, 3, 4, 6, 8, 10, 12 and 14Population: The analysis was performed on the Efficacy Set which included all participants from the Safety Set who provided a baseline and at least one post-baseline evaluable sputum sample. Only participants with data available for the specified analysis time points were included, and all were analysed according to the treatment they actually received.
Baseline was defined as the mean of Day -2 and Day -1. If data was available at only one of these timepoints, then that value was used as baseline.
Outcome measures
| Measure |
Standard of Care for Drug-sensitive Tuberculosis (DS - TB)_Cohort 1
n=9 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Linezolid
n=12 Participants
Participants received GSK3036656 20 mg + linezolid 600 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
GSK3036656 + Moxifloxacin
n=11 Participants
Participants received GSK3036656 20 mg + moxifloxacin 400 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Standard of Care for DS TB_Cohort 3
n=8 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Bedaquiline
n=13 Participants
Participants received GSK3036656 20 milligram (mg) + bedaquiline 400 mg once daily for 14 days; loading doses: 50 mg GSK3036656 (Day 1), 700 mg bedaquiline (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
|
GSK3036656 + Delamanid
n=15 Participants
Participants received GSK3036656 20 mg + delamanid 300 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Delamanid + Bedaquiline
n=16 Participants
Participants received delamanid 300 mg + bedaquiline 400 mg once daily for 14 days; bedaquiline loading doses: 700 mg (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
|
GSK3036656 + BTZ-043
n=14 Participants
Participants received GSK3036656 20 mg + BTZ-043 1000 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Standard of Care for DS-TB_Cohort 2
n=3 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Pretomanid
n=16 Participants
Participants received GSK3036656 20 mg + pretomanid 200 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in log10 Colony Forming Units (CFU) of Mycobacterium Tuberculosis (MTB)
Baseline
|
6.960 log10 CFU/milliliter (mL)
Standard Deviation 1.1038
|
6.691 log10 CFU/milliliter (mL)
Standard Deviation 0.6420
|
6.407 log10 CFU/milliliter (mL)
Standard Deviation 0.4622
|
6.583 log10 CFU/milliliter (mL)
Standard Deviation 0.5514
|
6.441 log10 CFU/milliliter (mL)
Standard Deviation 1.0053
|
6.387 log10 CFU/milliliter (mL)
Standard Deviation 0.9881
|
6.285 log10 CFU/milliliter (mL)
Standard Deviation 0.7599
|
6.457 log10 CFU/milliliter (mL)
Standard Deviation 1.0819
|
6.280 log10 CFU/milliliter (mL)
Standard Deviation 1.1045
|
6.522 log10 CFU/milliliter (mL)
Standard Deviation 0.7109
|
|
Change From Baseline in log10 Colony Forming Units (CFU) of Mycobacterium Tuberculosis (MTB)
Day 1
|
-0.876 log10 CFU/milliliter (mL)
Standard Deviation 0.7375
|
-0.150 log10 CFU/milliliter (mL)
Standard Deviation 0.3617
|
-0.598 log10 CFU/milliliter (mL)
Standard Deviation 1.0102
|
-0.218 log10 CFU/milliliter (mL)
Standard Deviation 0.7681
|
-0.323 log10 CFU/milliliter (mL)
Standard Deviation 0.6014
|
0.095 log10 CFU/milliliter (mL)
Standard Deviation 0.4192
|
-0.161 log10 CFU/milliliter (mL)
Standard Deviation 0.4819
|
0.028 log10 CFU/milliliter (mL)
Standard Deviation 0.3848
|
-0.369 log10 CFU/milliliter (mL)
Standard Deviation 0.3031
|
-0.002 log10 CFU/milliliter (mL)
Standard Deviation 0.5514
|
|
Change From Baseline in log10 Colony Forming Units (CFU) of Mycobacterium Tuberculosis (MTB)
Day 2
|
-1.524 log10 CFU/milliliter (mL)
Standard Deviation 0.5358
|
-0.485 log10 CFU/milliliter (mL)
Standard Deviation 0.7596
|
-0.490 log10 CFU/milliliter (mL)
Standard Deviation 0.3233
|
-1.137 log10 CFU/milliliter (mL)
Standard Deviation 0.3824
|
-0.251 log10 CFU/milliliter (mL)
Standard Deviation 0.6749
|
-0.431 log10 CFU/milliliter (mL)
Standard Deviation 1.2250
|
-0.465 log10 CFU/milliliter (mL)
Standard Deviation 0.8544
|
-0.186 log10 CFU/milliliter (mL)
Standard Deviation 0.6269
|
-0.638 log10 CFU/milliliter (mL)
Standard Deviation 0.4670
|
-0.218 log10 CFU/milliliter (mL)
Standard Deviation 0.7824
|
|
Change From Baseline in log10 Colony Forming Units (CFU) of Mycobacterium Tuberculosis (MTB)
Day 3
|
-1.995 log10 CFU/milliliter (mL)
Standard Deviation 1.0519
|
-0.445 log10 CFU/milliliter (mL)
Standard Deviation 0.6234
|
-1.096 log10 CFU/milliliter (mL)
Standard Deviation 0.9501
|
-1.196 log10 CFU/milliliter (mL)
Standard Deviation 0.6813
|
-0.314 log10 CFU/milliliter (mL)
Standard Deviation 0.7666
|
-0.525 log10 CFU/milliliter (mL)
Standard Deviation 0.4308
|
-0.393 log10 CFU/milliliter (mL)
Standard Deviation 0.7996
|
-0.316 log10 CFU/milliliter (mL)
Standard Deviation 0.5088
|
-1.000 log10 CFU/milliliter (mL)
Standard Deviation 0.4217
|
-0.453 log10 CFU/milliliter (mL)
Standard Deviation 0.6354
|
|
Change From Baseline in log10 Colony Forming Units (CFU) of Mycobacterium Tuberculosis (MTB)
Day 4
|
-1.961 log10 CFU/milliliter (mL)
Standard Deviation 0.6269
|
-0.961 log10 CFU/milliliter (mL)
Standard Deviation 0.7454
|
-0.870 log10 CFU/milliliter (mL)
Standard Deviation 0.5350
|
-1.691 log10 CFU/milliliter (mL)
Standard Deviation 0.0215
|
-0.749 log10 CFU/milliliter (mL)
Standard Deviation 0.6991
|
-0.559 log10 CFU/milliliter (mL)
Standard Deviation 0.9640
|
-0.302 log10 CFU/milliliter (mL)
Standard Deviation 0.8803
|
-0.637 log10 CFU/milliliter (mL)
Standard Deviation 0.5462
|
-1.236 log10 CFU/milliliter (mL)
Standard Deviation 0.6097
|
-0.541 log10 CFU/milliliter (mL)
Standard Deviation 0.6851
|
|
Change From Baseline in log10 Colony Forming Units (CFU) of Mycobacterium Tuberculosis (MTB)
Day 6
|
-1.792 log10 CFU/milliliter (mL)
Standard Deviation 0.2695
|
-1.185 log10 CFU/milliliter (mL)
Standard Deviation 0.5339
|
-1.669 log10 CFU/milliliter (mL)
Standard Deviation 1.3719
|
-1.655 log10 CFU/milliliter (mL)
Standard Deviation 1.0045
|
-0.908 log10 CFU/milliliter (mL)
Standard Deviation 1.0062
|
-1.192 log10 CFU/milliliter (mL)
Standard Deviation 0.6726
|
-0.686 log10 CFU/milliliter (mL)
Standard Deviation 0.8380
|
-0.675 log10 CFU/milliliter (mL)
Standard Deviation 0.8099
|
-1.698 log10 CFU/milliliter (mL)
Standard Deviation 0.8456
|
-0.696 log10 CFU/milliliter (mL)
Standard Deviation 0.6876
|
|
Change From Baseline in log10 Colony Forming Units (CFU) of Mycobacterium Tuberculosis (MTB)
Day 8
|
-2.123 log10 CFU/milliliter (mL)
Standard Deviation 0.9417
|
-1.502 log10 CFU/milliliter (mL)
Standard Deviation 0.4553
|
-1.346 log10 CFU/milliliter (mL)
Standard Deviation 0.5983
|
-1.867 log10 CFU/milliliter (mL)
Standard Deviation 0.8490
|
-1.405 log10 CFU/milliliter (mL)
Standard Deviation 0.6347
|
-1.417 log10 CFU/milliliter (mL)
Standard Deviation 0.8551
|
-0.759 log10 CFU/milliliter (mL)
Standard Deviation 0.8265
|
-1.004 log10 CFU/milliliter (mL)
Standard Deviation 0.7408
|
-2.061 log10 CFU/milliliter (mL)
Standard Deviation 1.0022
|
-1.186 log10 CFU/milliliter (mL)
Standard Deviation 0.5268
|
|
Change From Baseline in log10 Colony Forming Units (CFU) of Mycobacterium Tuberculosis (MTB)
Day 10
|
-2.642 log10 CFU/milliliter (mL)
Standard Deviation 0.4140
|
-1.427 log10 CFU/milliliter (mL)
Standard Deviation 0.8659
|
-1.145 log10 CFU/milliliter (mL)
Standard Deviation 0.5550
|
-1.708 log10 CFU/milliliter (mL)
Standard Deviation 1.2044
|
-1.143 log10 CFU/milliliter (mL)
Standard Deviation 0.8303
|
-1.568 log10 CFU/milliliter (mL)
Standard Deviation 0.7239
|
-0.679 log10 CFU/milliliter (mL)
Standard Deviation 0.7169
|
-1.137 log10 CFU/milliliter (mL)
Standard Deviation 0.6753
|
-2.289 log10 CFU/milliliter (mL)
Standard Deviation 1.9110
|
-1.187 log10 CFU/milliliter (mL)
Standard Deviation 0.7832
|
|
Change From Baseline in log10 Colony Forming Units (CFU) of Mycobacterium Tuberculosis (MTB)
Day 12
|
-2.533 log10 CFU/milliliter (mL)
Standard Deviation 0.5351
|
-1.726 log10 CFU/milliliter (mL)
Standard Deviation 0.8580
|
-1.701 log10 CFU/milliliter (mL)
Standard Deviation 0.9422
|
-2.340 log10 CFU/milliliter (mL)
Standard Deviation 1.4691
|
-1.242 log10 CFU/milliliter (mL)
Standard Deviation 1.0717
|
-1.461 log10 CFU/milliliter (mL)
Standard Deviation 0.5713
|
-1.171 log10 CFU/milliliter (mL)
Standard Deviation 1.0695
|
-1.528 log10 CFU/milliliter (mL)
Standard Deviation 1.1315
|
-2.278 log10 CFU/milliliter (mL)
Standard Deviation 1.7579
|
-1.286 log10 CFU/milliliter (mL)
Standard Deviation 0.5819
|
|
Change From Baseline in log10 Colony Forming Units (CFU) of Mycobacterium Tuberculosis (MTB)
Day 14
|
-2.784 log10 CFU/milliliter (mL)
Standard Deviation 0.6634
|
-2.164 log10 CFU/milliliter (mL)
Standard Deviation 1.4641
|
-1.782 log10 CFU/milliliter (mL)
Standard Deviation 0.7243
|
-2.312 log10 CFU/milliliter (mL)
Standard Deviation 1.2667
|
-1.088 log10 CFU/milliliter (mL)
Standard Deviation 0.5239
|
-1.845 log10 CFU/milliliter (mL)
Standard Deviation 0.7738
|
-0.684 log10 CFU/milliliter (mL)
Standard Deviation 1.1807
|
-1.478 log10 CFU/milliliter (mL)
Standard Deviation 0.8847
|
-1.001 log10 CFU/milliliter (mL)
Standard Deviation 1.2730
|
-1.676 log10 CFU/milliliter (mL)
Standard Deviation 0.7156
|
SECONDARY outcome
Timeframe: At Baseline and at days 1, 2, 3, 4, 6, 8, 10, 12 and 14Population: The analysis was performed on the Efficacy Set which included all participants from the Safety Set who provided a baseline and at least one post-baseline evaluable sputum sample. Only participants with data available for the specified analysis time points were included, and all were analysed according to the treatment they actually received.
Baseline was defined as the mean of Day -2 and Day -1. If data was available at only one of these timepoints, then that value was used as baseline.
Outcome measures
| Measure |
Standard of Care for Drug-sensitive Tuberculosis (DS - TB)_Cohort 1
n=9 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Linezolid
n=12 Participants
Participants received GSK3036656 20 mg + linezolid 600 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
GSK3036656 + Moxifloxacin
n=11 Participants
Participants received GSK3036656 20 mg + moxifloxacin 400 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Standard of Care for DS TB_Cohort 3
n=8 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Bedaquiline
n=13 Participants
Participants received GSK3036656 20 milligram (mg) + bedaquiline 400 mg once daily for 14 days; loading doses: 50 mg GSK3036656 (Day 1), 700 mg bedaquiline (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
|
GSK3036656 + Delamanid
n=15 Participants
Participants received GSK3036656 20 mg + delamanid 300 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Delamanid + Bedaquiline
n=16 Participants
Participants received delamanid 300 mg + bedaquiline 400 mg once daily for 14 days; bedaquiline loading doses: 700 mg (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
|
GSK3036656 + BTZ-043
n=14 Participants
Participants received GSK3036656 20 mg + BTZ-043 1000 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Standard of Care for DS-TB_Cohort 2
n=3 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Pretomanid
n=16 Participants
Participants received GSK3036656 20 mg + pretomanid 200 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Change From Baseline in Time to Sputum Culture Positivity
Day 4
|
0.320 log10 hours
Standard Deviation 0.0847
|
0.140 log10 hours
Standard Deviation 0.0634
|
0.181 log10 hours
Standard Deviation 0.0955
|
0.211 log10 hours
Standard Deviation 0.1102
|
0.234 log10 hours
Standard Deviation 0.0584
|
0.182 log10 hours
Standard Deviation 0.0685
|
0.142 log10 hours
Standard Deviation 0.0616
|
0.093 log10 hours
Standard Deviation 0.1009
|
0.232 log10 hours
Standard Deviation 0.0895
|
0.160 log10 hours
Standard Deviation 0.0544
|
|
Change From Baseline in Time to Sputum Culture Positivity
Day 6
|
0.344 log10 hours
Standard Deviation 0.1012
|
0.183 log10 hours
Standard Deviation 0.0990
|
0.237 log10 hours
Standard Deviation 0.1791
|
0.289 log10 hours
Standard Deviation 0.1049
|
0.295 log10 hours
Standard Deviation 0.1063
|
0.234 log10 hours
Standard Deviation 0.0665
|
0.165 log10 hours
Standard Deviation 0.0919
|
0.125 log10 hours
Standard Deviation 0.1005
|
0.302 log10 hours
Standard Deviation 0.0654
|
0.187 log10 hours
Standard Deviation 0.0486
|
|
Change From Baseline in Time to Sputum Culture Positivity
Day 8
|
0.364 log10 hours
Standard Deviation 0.1425
|
0.251 log10 hours
Standard Deviation 0.0779
|
0.267 log10 hours
Standard Deviation 0.1073
|
0.340 log10 hours
Standard Deviation 0.0968
|
0.327 log10 hours
Standard Deviation 0.1044
|
0.234 log10 hours
Standard Deviation 0.1165
|
0.236 log10 hours
Standard Deviation 0.1915
|
0.180 log10 hours
Standard Deviation 0.0967
|
0.210 log10 hours
Standard Deviation 0.3165
|
0.215 log10 hours
Standard Deviation 0.0772
|
|
Change From Baseline in Time to Sputum Culture Positivity
Day 10
|
0.401 log10 hours
Standard Deviation 0.0951
|
0.242 log10 hours
Standard Deviation 0.0976
|
0.286 log10 hours
Standard Deviation 0.0951
|
0.292 log10 hours
Standard Deviation 0.1206
|
0.367 log10 hours
Standard Deviation 0.1011
|
0.279 log10 hours
Standard Deviation 0.0749
|
0.223 log10 hours
Standard Deviation 0.0649
|
0.215 log10 hours
Standard Deviation 0.1119
|
0.299 log10 hours
Standard Deviation 0.2348
|
0.276 log10 hours
Standard Deviation 0.0722
|
|
Change From Baseline in Time to Sputum Culture Positivity
Day 12
|
0.361 log10 hours
Standard Deviation 0.0424
|
0.317 log10 hours
Standard Deviation 0.0991
|
0.251 log10 hours
Standard Deviation 0.1546
|
0.355 log10 hours
Standard Deviation 0.1764
|
0.389 log10 hours
Standard Deviation 0.1344
|
0.294 log10 hours
Standard Deviation 0.0748
|
0.290 log10 hours
Standard Deviation 0.1459
|
0.232 log10 hours
Standard Deviation 0.0907
|
0.337 log10 hours
Standard Deviation 0.1660
|
0.287 log10 hours
Standard Deviation 0.0708
|
|
Change From Baseline in Time to Sputum Culture Positivity
Day 14
|
0.434 log10 hours
Standard Deviation 0.0714
|
0.267 log10 hours
Standard Deviation 0.0955
|
0.323 log10 hours
Standard Deviation 0.1045
|
0.362 log10 hours
Standard Deviation 0.1319
|
0.376 log10 hours
Standard Deviation 0.0938
|
0.328 log10 hours
Standard Deviation 0.1019
|
0.330 log10 hours
Standard Deviation 0.1773
|
0.273 log10 hours
Standard Deviation 0.1296
|
0.258 log10 hours
Standard Deviation 0.0591
|
0.344 log10 hours
Standard Deviation 0.0729
|
|
Change From Baseline in Time to Sputum Culture Positivity
Baseline
|
1.987 log10 hours
Standard Deviation 0.1350
|
2.002 log10 hours
Standard Deviation 0.0798
|
2.023 log10 hours
Standard Deviation 0.0819
|
2.002 log10 hours
Standard Deviation 0.1120
|
2.016 log10 hours
Standard Deviation 0.1253
|
2.039 log10 hours
Standard Deviation 0.1316
|
2.057 log10 hours
Standard Deviation 0.0947
|
2.077 log10 hours
Standard Deviation 0.1713
|
2.079 log10 hours
Standard Deviation 0.1144
|
2.000 log10 hours
Standard Deviation 0.0936
|
|
Change From Baseline in Time to Sputum Culture Positivity
Day 1
|
0.143 log10 hours
Standard Deviation 0.0868
|
0.030 log10 hours
Standard Deviation 0.0472
|
0.079 log10 hours
Standard Deviation 0.0847
|
0.082 log10 hours
Standard Deviation 0.0749
|
0.077 log10 hours
Standard Deviation 0.0799
|
0.009 log10 hours
Standard Deviation 0.0525
|
0.037 log10 hours
Standard Deviation 0.0505
|
-0.004 log10 hours
Standard Deviation 0.0989
|
0.098 log10 hours
Standard Deviation 0.0716
|
0.010 log10 hours
Standard Deviation 0.0394
|
|
Change From Baseline in Time to Sputum Culture Positivity
Day 2
|
0.243 log10 hours
Standard Deviation 0.0487
|
0.078 log10 hours
Standard Deviation 0.0731
|
0.139 log10 hours
Standard Deviation 0.0761
|
0.199 log10 hours
Standard Deviation 0.0975
|
0.172 log10 hours
Standard Deviation 0.0637
|
0.096 log10 hours
Standard Deviation 0.0700
|
0.089 log10 hours
Standard Deviation 0.0614
|
0.041 log10 hours
Standard Deviation 0.0972
|
0.167 log10 hours
Standard Deviation 0.0528
|
0.089 log10 hours
Standard Deviation 0.0894
|
|
Change From Baseline in Time to Sputum Culture Positivity
Day 3
|
0.266 log10 hours
Standard Deviation 0.0706
|
0.121 log10 hours
Standard Deviation 0.0686
|
0.153 log10 hours
Standard Deviation 0.0574
|
0.212 log10 hours
Standard Deviation 0.1004
|
0.222 log10 hours
Standard Deviation 0.0757
|
0.129 log10 hours
Standard Deviation 0.0690
|
0.170 log10 hours
Standard Deviation 0.1878
|
0.053 log10 hours
Standard Deviation 0.0676
|
0.197 log10 hours
Standard Deviation 0.0298
|
0.122 log10 hours
Standard Deviation 0.0730
|
SECONDARY outcome
Timeframe: From Day 1 to Day 28Population: The analysis was performed on the Safety Set which included all participants who received at least 1 dose of study intervention. Only participants with data available for the specified analysis time period were included, and all were analysed according to the treatment they actually received.
An SAE was defined as any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, caused a congenital anomaly/birth defect, or was any other situation identified according to medical or scientific judgment.
Outcome measures
| Measure |
Standard of Care for Drug-sensitive Tuberculosis (DS - TB)_Cohort 1
n=9 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Linezolid
n=13 Participants
Participants received GSK3036656 20 mg + linezolid 600 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
GSK3036656 + Moxifloxacin
n=14 Participants
Participants received GSK3036656 20 mg + moxifloxacin 400 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Standard of Care for DS TB_Cohort 3
n=11 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Bedaquiline
n=14 Participants
Participants received GSK3036656 20 milligram (mg) + bedaquiline 400 mg once daily for 14 days; loading doses: 50 mg GSK3036656 (Day 1), 700 mg bedaquiline (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
|
GSK3036656 + Delamanid
n=15 Participants
Participants received GSK3036656 20 mg + delamanid 300 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Delamanid + Bedaquiline
n=16 Participants
Participants received delamanid 300 mg + bedaquiline 400 mg once daily for 14 days; bedaquiline loading doses: 700 mg (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
|
GSK3036656 + BTZ-043
n=14 Participants
Participants received GSK3036656 20 mg + BTZ-043 1000 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Standard of Care for DS-TB_Cohort 2
n=3 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Pretomanid
n=16 Participants
Participants received GSK3036656 20 mg + pretomanid 200 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 1 to Day 28Population: The analysis was performed on the Safety Set which included all participants who received at least 1 dose of study intervention. Only participants with data available for the specified analysis time period were included, and all were analysed according to the treatment they actually received.
An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not it was considered related to the study intervention. The intensity of AEs was assessed using the Division of Acquired Immunodeficiency Syndrome (DAIDS) criteria Version 2.1, where grades were defined based on numeric criteria as follows: Grade 1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: potentially life-threatening; Grade 5: death. A higher grade indicated greater severity. Any = occurrence of the event regardless of intensity grade.
Outcome measures
| Measure |
Standard of Care for Drug-sensitive Tuberculosis (DS - TB)_Cohort 1
n=9 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Linezolid
n=13 Participants
Participants received GSK3036656 20 mg + linezolid 600 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
GSK3036656 + Moxifloxacin
n=14 Participants
Participants received GSK3036656 20 mg + moxifloxacin 400 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Standard of Care for DS TB_Cohort 3
n=11 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Bedaquiline
n=14 Participants
Participants received GSK3036656 20 milligram (mg) + bedaquiline 400 mg once daily for 14 days; loading doses: 50 mg GSK3036656 (Day 1), 700 mg bedaquiline (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
|
GSK3036656 + Delamanid
n=15 Participants
Participants received GSK3036656 20 mg + delamanid 300 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Delamanid + Bedaquiline
n=16 Participants
Participants received delamanid 300 mg + bedaquiline 400 mg once daily for 14 days; bedaquiline loading doses: 700 mg (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
|
GSK3036656 + BTZ-043
n=14 Participants
Participants received GSK3036656 20 mg + BTZ-043 1000 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Standard of Care for DS-TB_Cohort 2
n=3 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Pretomanid
n=16 Participants
Participants received GSK3036656 20 mg + pretomanid 200 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AE) of Grade 3 Severity or Higher
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Events (AE) of Grade 3 Severity or Higher
Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AE) of Grade 3 Severity or Higher
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 1 to Day 28Population: The analysis was performed on the Safety Set which included all participants who received at least 1 dose of study intervention. Only participants with data available for the specified analysis time period were included, and all were analysed according to the treatment they actually received.
Outcome measures
| Measure |
Standard of Care for Drug-sensitive Tuberculosis (DS - TB)_Cohort 1
n=9 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Linezolid
n=13 Participants
Participants received GSK3036656 20 mg + linezolid 600 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
GSK3036656 + Moxifloxacin
n=14 Participants
Participants received GSK3036656 20 mg + moxifloxacin 400 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Standard of Care for DS TB_Cohort 3
n=11 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Bedaquiline
n=14 Participants
Participants received GSK3036656 20 milligram (mg) + bedaquiline 400 mg once daily for 14 days; loading doses: 50 mg GSK3036656 (Day 1), 700 mg bedaquiline (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
|
GSK3036656 + Delamanid
n=15 Participants
Participants received GSK3036656 20 mg + delamanid 300 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Delamanid + Bedaquiline
n=16 Participants
Participants received delamanid 300 mg + bedaquiline 400 mg once daily for 14 days; bedaquiline loading doses: 700 mg (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
|
GSK3036656 + BTZ-043
n=14 Participants
Participants received GSK3036656 20 mg + BTZ-043 1000 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Standard of Care for DS-TB_Cohort 2
n=3 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Pretomanid
n=16 Participants
Participants received GSK3036656 20 mg + pretomanid 200 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events Related to Study Treatment
|
5 Participants
|
4 Participants
|
7 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
6 Participants
|
7 Participants
|
1 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From Day 1 to Day 28Population: The analysis was performed on the Safety Set which included all participants who received at least 1 dose of study intervention. Only participants with data available for the specified analysis time period were included, and all were analysed according to the treatment they actually received.
Outcome measures
| Measure |
Standard of Care for Drug-sensitive Tuberculosis (DS - TB)_Cohort 1
n=9 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Linezolid
n=13 Participants
Participants received GSK3036656 20 mg + linezolid 600 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
GSK3036656 + Moxifloxacin
n=14 Participants
Participants received GSK3036656 20 mg + moxifloxacin 400 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Standard of Care for DS TB_Cohort 3
n=11 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Bedaquiline
n=14 Participants
Participants received GSK3036656 20 milligram (mg) + bedaquiline 400 mg once daily for 14 days; loading doses: 50 mg GSK3036656 (Day 1), 700 mg bedaquiline (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
|
GSK3036656 + Delamanid
n=15 Participants
Participants received GSK3036656 20 mg + delamanid 300 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Delamanid + Bedaquiline
n=16 Participants
Participants received delamanid 300 mg + bedaquiline 400 mg once daily for 14 days; bedaquiline loading doses: 700 mg (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
|
GSK3036656 + BTZ-043
n=14 Participants
Participants received GSK3036656 20 mg + BTZ-043 1000 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Standard of Care for DS-TB_Cohort 2
n=3 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Pretomanid
n=16 Participants
Participants received GSK3036656 20 mg + pretomanid 200 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Withdrawn From the Treatment Due to Adverse Events
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From Day 1 to Day 28Population: The analysis was performed on the Safety Set which included all participants who received at least 1 dose of study intervention. Only participants with data available for the specified analysis time period were included, and all were analysed according to the treatment they actually received.
Outcome measures
| Measure |
Standard of Care for Drug-sensitive Tuberculosis (DS - TB)_Cohort 1
n=9 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Linezolid
n=13 Participants
Participants received GSK3036656 20 mg + linezolid 600 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
GSK3036656 + Moxifloxacin
n=14 Participants
Participants received GSK3036656 20 mg + moxifloxacin 400 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Standard of Care for DS TB_Cohort 3
n=11 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Bedaquiline
n=14 Participants
Participants received GSK3036656 20 milligram (mg) + bedaquiline 400 mg once daily for 14 days; loading doses: 50 mg GSK3036656 (Day 1), 700 mg bedaquiline (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
|
GSK3036656 + Delamanid
n=15 Participants
Participants received GSK3036656 20 mg + delamanid 300 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Delamanid + Bedaquiline
n=16 Participants
Participants received delamanid 300 mg + bedaquiline 400 mg once daily for 14 days; bedaquiline loading doses: 700 mg (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
|
GSK3036656 + BTZ-043
n=14 Participants
Participants received GSK3036656 20 mg + BTZ-043 1000 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Standard of Care for DS-TB_Cohort 2
n=3 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Pretomanid
n=16 Participants
Participants received GSK3036656 20 mg + pretomanid 200 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Withdrawn From the Study Due to Adverse Events
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 1 to Day 28Population: The analysis was performed on the Safety Set which included all participants who received at least 1 dose of study intervention. Only participants with data available for the specified analysis time period were included, and all were analysed according to the treatment they actually received.
PCI ECG values were defined as any ECG findings which, in the opinion of the investigator or medical monitor, would have interfered with the safety of the individual participant. The ECG measurements analyzed were PR Interval, QRS Duration, and QTcF Interval. A value was reported as "high" for a period if it had shifted from "low" or "within range" (W/in) at the start of the treatment period but was "high" during or at the end of the same treatment period. A value was reported as "low" for a period if it had shifted from "high" or "W/in" at the start of the treatment period but was "low" during or at the end of the same treatment period. A value was reported as "No Change" if it had remained unchanged (e.g., High to High), or as "To W/in Range" if it had been within range.
Outcome measures
| Measure |
Standard of Care for Drug-sensitive Tuberculosis (DS - TB)_Cohort 1
n=9 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Linezolid
n=13 Participants
Participants received GSK3036656 20 mg + linezolid 600 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
GSK3036656 + Moxifloxacin
n=14 Participants
Participants received GSK3036656 20 mg + moxifloxacin 400 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Standard of Care for DS TB_Cohort 3
n=11 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Bedaquiline
n=14 Participants
Participants received GSK3036656 20 milligram (mg) + bedaquiline 400 mg once daily for 14 days; loading doses: 50 mg GSK3036656 (Day 1), 700 mg bedaquiline (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
|
GSK3036656 + Delamanid
n=15 Participants
Participants received GSK3036656 20 mg + delamanid 300 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Delamanid + Bedaquiline
n=16 Participants
Participants received delamanid 300 mg + bedaquiline 400 mg once daily for 14 days; bedaquiline loading doses: 700 mg (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
|
GSK3036656 + BTZ-043
n=14 Participants
Participants received GSK3036656 20 mg + BTZ-043 1000 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Standard of Care for DS-TB_Cohort 2
n=3 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Pretomanid
n=16 Participants
Participants received GSK3036656 20 mg + pretomanid 200 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI)
PR Interval, To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI)
PR Interval, To W/in Range or No Change
|
9 Participants
|
13 Participants
|
12 Participants
|
11 Participants
|
13 Participants
|
15 Participants
|
16 Participants
|
14 Participants
|
3 Participants
|
16 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI)
PR Interval, To High
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI)
QRS Duration, To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI)
QRS Duration, To W/in Range or No Change
|
9 Participants
|
13 Participants
|
13 Participants
|
11 Participants
|
14 Participants
|
14 Participants
|
16 Participants
|
14 Participants
|
3 Participants
|
16 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI)
QRS Duration, To High
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI)
QTcF Interval, To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI)
QTcF Interval, To W/in Range or No Change
|
9 Participants
|
11 Participants
|
14 Participants
|
11 Participants
|
14 Participants
|
13 Participants
|
14 Participants
|
14 Participants
|
3 Participants
|
15 Participants
|
|
Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI)
QTcF Interval, To High
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From Day 1 to Day 28Population: The analysis was performed on the Safety Set which included all participants who received at least 1 dose of study intervention. Only participants with data available for the specified analysis time period were included, and all were analysed according to the treatment they actually received.
The analyzed hematology parameters were hematocrits, hemoglobin, lymphocytes, neutrophils, and platelets. A value was reported as "high" for a period if it had shifted from "low" or "within range" (W/in) at the start of the treatment period but was "high" during or at the end of the same treatment period. A value was reported as "low" for a period if it had shifted from "high" or "W/in" at the start of the treatment period but was "low" during or at the end of the same treatment period. A value was reported as "No Change" if it had remained unchanged (e.g., High to High), or as "To W/in Range" if it had been within range.
Outcome measures
| Measure |
Standard of Care for Drug-sensitive Tuberculosis (DS - TB)_Cohort 1
n=9 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Linezolid
n=13 Participants
Participants received GSK3036656 20 mg + linezolid 600 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
GSK3036656 + Moxifloxacin
n=14 Participants
Participants received GSK3036656 20 mg + moxifloxacin 400 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Standard of Care for DS TB_Cohort 3
n=11 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Bedaquiline
n=14 Participants
Participants received GSK3036656 20 milligram (mg) + bedaquiline 400 mg once daily for 14 days; loading doses: 50 mg GSK3036656 (Day 1), 700 mg bedaquiline (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
|
GSK3036656 + Delamanid
n=15 Participants
Participants received GSK3036656 20 mg + delamanid 300 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Delamanid + Bedaquiline
n=16 Participants
Participants received delamanid 300 mg + bedaquiline 400 mg once daily for 14 days; bedaquiline loading doses: 700 mg (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
|
GSK3036656 + BTZ-043
n=14 Participants
Participants received GSK3036656 20 mg + BTZ-043 1000 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Standard of Care for DS-TB_Cohort 2
n=3 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Pretomanid
n=16 Participants
Participants received GSK3036656 20 mg + pretomanid 200 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Hematology Laboratory Values of PCI
Hemoglobin, To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Laboratory Values of PCI
Hematocrit, To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Laboratory Values of PCI
Hematocrit, To W/in Range or No Change
|
9 Participants
|
13 Participants
|
14 Participants
|
11 Participants
|
14 Participants
|
15 Participants
|
15 Participants
|
14 Participants
|
3 Participants
|
16 Participants
|
|
Number of Participants With Hematology Laboratory Values of PCI
Hematocrit, To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Laboratory Values of PCI
Hemoglobin, To W/in Range or No Change
|
9 Participants
|
13 Participants
|
14 Participants
|
11 Participants
|
14 Participants
|
14 Participants
|
16 Participants
|
14 Participants
|
3 Participants
|
16 Participants
|
|
Number of Participants With Hematology Laboratory Values of PCI
Hemoglobin, To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Laboratory Values of PCI
Lymphocytes, To Low
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Hematology Laboratory Values of PCI
Lymphocytes, To W/in Range or No Change
|
9 Participants
|
11 Participants
|
14 Participants
|
11 Participants
|
14 Participants
|
14 Participants
|
16 Participants
|
13 Participants
|
3 Participants
|
15 Participants
|
|
Number of Participants With Hematology Laboratory Values of PCI
Lymphocytes, To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Laboratory Values of PCI
Neutrophils, To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Laboratory Values of PCI
Neutrophils, To W/in Range or No Change
|
9 Participants
|
13 Participants
|
14 Participants
|
11 Participants
|
14 Participants
|
14 Participants
|
16 Participants
|
14 Participants
|
3 Participants
|
16 Participants
|
|
Number of Participants With Hematology Laboratory Values of PCI
Neutrophils, To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Laboratory Values of PCI
Platelets, To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematology Laboratory Values of PCI
Platelets, To W/in Range or No Change
|
8 Participants
|
10 Participants
|
13 Participants
|
11 Participants
|
14 Participants
|
12 Participants
|
12 Participants
|
12 Participants
|
3 Participants
|
13 Participants
|
|
Number of Participants With Hematology Laboratory Values of PCI
Platelets, To High
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: From Day 1 to Day 28Population: The analysis was performed on the Safety Set which included all participants who received at least 1 dose of study intervention. Only participants with data available for the specified analysis time period were included, and all were analysed according to the treatment they actually received.
The chemistry parameters analyzed were glucose, alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, calcium, creatinine, potassium, and sodium. A value was reported as "high" for a period if it had shifted from "low" or "within range" (W/in) at the start of the treatment period but was "high" during or at the end of the same treatment period. A value was reported as "low" for a period if it had shifted from "high" or "W/in" at the start of the treatment period but was "low" during or at the end of the same treatment period. A value was reported as "No Change" if it had remained unchanged (e.g., High to High), or as "To W/in Range" if it had been within range.
Outcome measures
| Measure |
Standard of Care for Drug-sensitive Tuberculosis (DS - TB)_Cohort 1
n=9 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Linezolid
n=13 Participants
Participants received GSK3036656 20 mg + linezolid 600 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
GSK3036656 + Moxifloxacin
n=14 Participants
Participants received GSK3036656 20 mg + moxifloxacin 400 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Standard of Care for DS TB_Cohort 3
n=11 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Bedaquiline
n=14 Participants
Participants received GSK3036656 20 milligram (mg) + bedaquiline 400 mg once daily for 14 days; loading doses: 50 mg GSK3036656 (Day 1), 700 mg bedaquiline (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
|
GSK3036656 + Delamanid
n=15 Participants
Participants received GSK3036656 20 mg + delamanid 300 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Delamanid + Bedaquiline
n=16 Participants
Participants received delamanid 300 mg + bedaquiline 400 mg once daily for 14 days; bedaquiline loading doses: 700 mg (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
|
GSK3036656 + BTZ-043
n=14 Participants
Participants received GSK3036656 20 mg + BTZ-043 1000 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Standard of Care for DS-TB_Cohort 2
n=3 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Pretomanid
n=16 Participants
Participants received GSK3036656 20 mg + pretomanid 200 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinical Chemistry Laboratory Values of PCI
ALT, To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Values of PCI
ALT, To W/in Range or No Change
|
9 Participants
|
13 Participants
|
12 Participants
|
11 Participants
|
14 Participants
|
14 Participants
|
16 Participants
|
14 Participants
|
3 Participants
|
15 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Values of PCI
ALT, To High
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Values of PCI
AST, To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Values of PCI
AST, To W/in Range or No Change
|
9 Participants
|
12 Participants
|
14 Participants
|
11 Participants
|
14 Participants
|
15 Participants
|
16 Participants
|
14 Participants
|
3 Participants
|
16 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Values of PCI
AST, To High
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Values of PCI
Bilirubin, To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Values of PCI
Bilirubin, To W/in Range or No Change
|
9 Participants
|
13 Participants
|
14 Participants
|
11 Participants
|
14 Participants
|
15 Participants
|
16 Participants
|
14 Participants
|
3 Participants
|
16 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Values of PCI
Bilirubin, To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Values of PCI
Calcium, To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Values of PCI
Calcium, To W/in Range or No Change
|
9 Participants
|
13 Participants
|
14 Participants
|
11 Participants
|
13 Participants
|
15 Participants
|
16 Participants
|
14 Participants
|
3 Participants
|
16 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Values of PCI
Calcium, To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Values of PCI
Creatinine, To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Values of PCI
Creatinine, To W/in Range or No Change
|
8 Participants
|
12 Participants
|
14 Participants
|
10 Participants
|
14 Participants
|
13 Participants
|
16 Participants
|
11 Participants
|
2 Participants
|
15 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Values of PCI
Creatinine, To High
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Values of PCI
Potassium, To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Values of PCI
Potassium, To W/in Range or No Change
|
8 Participants
|
11 Participants
|
13 Participants
|
11 Participants
|
13 Participants
|
13 Participants
|
13 Participants
|
12 Participants
|
3 Participants
|
14 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Values of PCI
Potassium, To High
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Values of PCI
Sodium, To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Values of PCI
Sodium, To W/in Range or No Change
|
9 Participants
|
13 Participants
|
14 Participants
|
11 Participants
|
14 Participants
|
15 Participants
|
16 Participants
|
14 Participants
|
3 Participants
|
16 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Values of PCI
Sodium, To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Values of PCI
Glucose, To Low
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Values of PCI
Glucose, To W/in Range or No Change
|
8 Participants
|
12 Participants
|
14 Participants
|
11 Participants
|
14 Participants
|
15 Participants
|
16 Participants
|
14 Participants
|
3 Participants
|
15 Participants
|
|
Number of Participants With Clinical Chemistry Laboratory Values of PCI
Glucose, To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From Day 1 to Day 28Population: The analysis was performed on the Safety Set which included all participants who received at least 1 dose of study intervention. Only participants with data available for the specified analysis time period were included, and all were analysed according to the treatment they actually received.
The analyzed vital signs were systolic blood pressure, diastolic blood pressure, pulse rate. A value was reported as "high" for a period if it had shifted from "low" or "within range" (W/in) at the start of the treatment period but was "high" during or at the end of the same treatment period. A value was reported as "low" for a period if it had shifted from "high" or "W/in" at the start of the treatment period but was "low" during or at the end of the same treatment period. A value was reported as "No Change" if it had remained unchanged (e.g., High to High), or as "To W/in Range" if it had been within range.
Outcome measures
| Measure |
Standard of Care for Drug-sensitive Tuberculosis (DS - TB)_Cohort 1
n=9 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Linezolid
n=13 Participants
Participants received GSK3036656 20 mg + linezolid 600 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
GSK3036656 + Moxifloxacin
n=14 Participants
Participants received GSK3036656 20 mg + moxifloxacin 400 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Standard of Care for DS TB_Cohort 3
n=11 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Bedaquiline
n=14 Participants
Participants received GSK3036656 20 milligram (mg) + bedaquiline 400 mg once daily for 14 days; loading doses: 50 mg GSK3036656 (Day 1), 700 mg bedaquiline (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
|
GSK3036656 + Delamanid
n=15 Participants
Participants received GSK3036656 20 mg + delamanid 300 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Delamanid + Bedaquiline
n=16 Participants
Participants received delamanid 300 mg + bedaquiline 400 mg once daily for 14 days; bedaquiline loading doses: 700 mg (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
|
GSK3036656 + BTZ-043
n=14 Participants
Participants received GSK3036656 20 mg + BTZ-043 1000 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Standard of Care for DS-TB_Cohort 2
n=3 Participants
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Pretomanid
n=16 Participants
Participants received GSK3036656 20 mg + pretomanid 200 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Vital Signs of PCI
Systolic Blood Pressure, To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs of PCI
Systolic Blood Pressure, To W/in Range or No Change
|
9 Participants
|
13 Participants
|
14 Participants
|
11 Participants
|
14 Participants
|
15 Participants
|
16 Participants
|
14 Participants
|
3 Participants
|
16 Participants
|
|
Number of Participants With Vital Signs of PCI
Systolic Blood Pressure, To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs of PCI
Diastolic Blood Pressure, To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs of PCI
Diastolic Blood Pressure, To W/in Range or No Change
|
9 Participants
|
13 Participants
|
14 Participants
|
11 Participants
|
14 Participants
|
15 Participants
|
16 Participants
|
12 Participants
|
3 Participants
|
16 Participants
|
|
Number of Participants With Vital Signs of PCI
Diastolic Blood Pressure, To High
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs of PCI
Pulse Rate, To Low
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs of PCI
Pulse Rate, To W/in Range or No Change
|
9 Participants
|
12 Participants
|
12 Participants
|
10 Participants
|
14 Participants
|
14 Participants
|
15 Participants
|
9 Participants
|
3 Participants
|
16 Participants
|
|
Number of Participants With Vital Signs of PCI
Pulse Rate, To High
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Standard of Care for Drug-sensitive Tuberculosis (DS - TB)_Cohort 1
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
GSK3036656 + Bedaquiline
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
GSK3036656 + Delamanid
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Delamanid + Bedaquiline
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
GSK3036656 + BTZ-043
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Standard of Care for DS - TB_Cohort 2
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
GSK3036656 + Pretomanid
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
GSK3036656 + Linezolid
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
GSK3036656 + Moxifloxacin
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Standard of Care for DS TB_Cohort 3
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard of Care for Drug-sensitive Tuberculosis (DS - TB)_Cohort 1
n=9 participants at risk
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Bedaquiline
n=14 participants at risk
Participants received GSK3036656 20 milligram (mg) + bedaquiline 400 mg once daily for 14 days; loading doses: 50 mg GSK3036656 (Day 1), 700 mg bedaquiline (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
|
GSK3036656 + Delamanid
n=15 participants at risk
Participants received GSK3036656 20 mg + delamanid 300 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Delamanid + Bedaquiline
n=16 participants at risk
Participants received delamanid 300 mg + bedaquiline 400 mg once daily for 14 days; bedaquiline loading doses: 700 mg (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
|
GSK3036656 + BTZ-043
n=14 participants at risk
Participants received GSK3036656 20 mg + BTZ-043 1000 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Standard of Care for DS - TB_Cohort 2
n=3 participants at risk
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Pretomanid
n=16 participants at risk
Participants received GSK3036656 20 mg + pretomanid 200 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
GSK3036656 + Linezolid
n=13 participants at risk
GSK3036656 20 mg + linezolid 600 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
GSK3036656 + Moxifloxacin
n=14 participants at risk
Participants received GSK3036656 20 mg + moxifloxacin 400 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Standard of Care for DS TB_Cohort 3
n=11 participants at risk
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Seizure
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.7%
1/13 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
Other adverse events
| Measure |
Standard of Care for Drug-sensitive Tuberculosis (DS - TB)_Cohort 1
n=9 participants at risk
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Bedaquiline
n=14 participants at risk
Participants received GSK3036656 20 milligram (mg) + bedaquiline 400 mg once daily for 14 days; loading doses: 50 mg GSK3036656 (Day 1), 700 mg bedaquiline (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
|
GSK3036656 + Delamanid
n=15 participants at risk
Participants received GSK3036656 20 mg + delamanid 300 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Delamanid + Bedaquiline
n=16 participants at risk
Participants received delamanid 300 mg + bedaquiline 400 mg once daily for 14 days; bedaquiline loading doses: 700 mg (Day 1), 500 mg (Day 2), then 400 mg daily (Days 3-14).
|
GSK3036656 + BTZ-043
n=14 participants at risk
Participants received GSK3036656 20 mg + BTZ-043 1000 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Standard of Care for DS - TB_Cohort 2
n=3 participants at risk
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
GSK3036656 + Pretomanid
n=16 participants at risk
Participants received GSK3036656 20 mg + pretomanid 200 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
GSK3036656 + Linezolid
n=13 participants at risk
GSK3036656 20 mg + linezolid 600 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
GSK3036656 + Moxifloxacin
n=14 participants at risk
Participants received GSK3036656 20 mg + moxifloxacin 400 mg once daily for 14 days; 50 mg GSK3036656 loading dose on Day 1.
|
Standard of Care for DS TB_Cohort 3
n=11 participants at risk
Participants received Rifafour e-275 (or equivalent generic) once daily for 14 days.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Dry eye
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Eye disorders
Eye irritation
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
9.1%
1/11 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
33.3%
1/3 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.2%
1/16 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Gastrointestinal disorders
Anal pruritus
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.7%
1/13 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.7%
1/15 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.2%
1/16 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.2%
1/16 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.2%
1/16 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
15.4%
2/13 • Number of events 2 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
14.3%
2/14 • Number of events 2 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.2%
1/16 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
9.1%
1/11 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Gastrointestinal disorders
Gastritis
|
11.1%
1/9 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
9.1%
1/11 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Gastrointestinal disorders
Nausea
|
22.2%
2/9 • Number of events 2 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
21.4%
3/14 • Number of events 3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
20.0%
3/15 • Number of events 3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
12.5%
2/16 • Number of events 2 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
14.3%
2/14 • Number of events 2 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.2%
1/16 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
15.4%
2/13 • Number of events 2 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
9.1%
1/11 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
9.1%
1/11 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.2%
1/16 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
15.4%
2/13 • Number of events 2 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
9.1%
1/11 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Gastrointestinal disorders
Vomiting
|
11.1%
1/9 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
13.3%
2/15 • Number of events 2 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.2%
1/16 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
General disorders
Influenza like illness
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.7%
1/15 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Nervous system disorders
Headache
|
33.3%
3/9 • Number of events 3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
14.3%
2/14 • Number of events 2 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
12.5%
2/16 • Number of events 2 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
21.4%
3/14 • Number of events 3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
9.1%
1/11 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
9.1%
1/11 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Nervous system disorders
Somnolence
|
11.1%
1/9 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
13.3%
2/15 • Number of events 2 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.2%
1/16 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
21.4%
3/14 • Number of events 3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
9.1%
1/11 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Nervous system disorders
Syncope
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.2%
1/16 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.7%
1/15 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
14.3%
2/14 • Number of events 2 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.7%
1/13 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
14.3%
2/14 • Number of events 2 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.2%
1/16 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Cardiac disorders
Rhythm idioventricular
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.2%
1/16 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.2%
1/16 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.2%
1/16 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Gastrointestinal disorders
Post-tussive vomiting
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
General disorders
Pain
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
9.1%
1/11 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Infections and infestations
Body tinea
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.2%
1/16 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Infections and infestations
Gingivitis
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.2%
1/16 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Infections and infestations
Periodontitis
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.7%
1/15 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Infections and infestations
Pneumonia
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.2%
1/16 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
9.1%
1/11 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.7%
1/15 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Infections and infestations
Tuberculous pleurisy
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.2%
1/16 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.7%
1/15 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.2%
1/16 • Number of events 3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.2%
1/16 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.2%
1/16 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Investigations
Electrocardiogram PR prolongation
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
14.3%
2/14 • Number of events 2 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.7%
1/13 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.2%
1/16 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
21.4%
3/14 • Number of events 3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.7%
1/13 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.7%
1/15 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Metabolism and nutrition disorders
Increased appetite
|
11.1%
1/9 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
14.3%
2/14 • Number of events 2 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
18.8%
3/16 • Number of events 3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.7%
1/13 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
9.1%
1/11 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
22.2%
2/9 • Number of events 2 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
20.0%
3/15 • Number of events 3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
12.5%
2/16 • Number of events 2 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
14.3%
2/14 • Number of events 2 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
11.1%
1/9 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.2%
1/16 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
1/9 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.2%
1/16 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
9.1%
1/11 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
33.3%
1/3 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
1/9 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Nervous system disorders
Dizziness
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
12.5%
2/16 • Number of events 2 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
21.4%
3/14 • Number of events 3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
14.3%
2/14 • Number of events 2 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
9.1%
1/11 • Number of events 2 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
1/9 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.2%
1/16 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
22.2%
2/9 • Number of events 2 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.7%
1/15 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
33.3%
1/3 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
12.5%
2/16 • Number of events 2 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
9.1%
1/11 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.1%
1/9 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
20.0%
3/15 • Number of events 3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.2%
1/16 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.7%
1/15 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.7%
1/13 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
11.1%
1/9 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.7%
1/15 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
44.4%
4/9 • Number of events 5 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
14.3%
2/14 • Number of events 2 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.7%
1/15 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
25.0%
4/16 • Number of events 4 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
33.3%
1/3 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.7%
1/13 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
18.2%
2/11 • Number of events 2 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.2%
1/16 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.7%
1/13 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
14.3%
2/14 • Number of events 3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
9.1%
1/11 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.2%
1/16 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
11.1%
1/9 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
13.3%
2/15 • Number of events 2 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
33.3%
1/3 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.2%
1/16 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
18.2%
2/11 • Number of events 2 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.2%
1/16 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
6.7%
1/15 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
11.1%
1/9 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Vascular disorders
Hot flush
|
11.1%
1/9 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Vascular disorders
Hypertension
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
14.3%
2/14 • Number of events 3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/9 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/15 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
7.1%
1/14 • Number of events 1 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/3 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/16 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/13 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/14 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
0.00%
0/11 • Adverse events and serious AEs were reported from Day 1 to Day 28
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER